SANCUSO

Product NDC: 66220-637
11-digit product format: 662200637
Labeler code: 66220
Product ID: 66220-637_c78db5de-683f-41bd-8f25-700b9d0e2e46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: granisetron
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Cumberland Pharmaceuticals Inc.
Application: NDA022198
Marketing category: NDA
Marketing start: 2024-07-16
Substance: GRANISETRON
Active strength: 3.1 mg/24h
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022198-001	SANCUSO	GRANISETRON	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2008-09-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022198-001	SANCUSO	3.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2008-09-12	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022198-001	7608282	2025-01-22	U-1011	Drug product	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022198-001	7608282	2025-01-22	U-1011	Drug product	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022198-001	7608282	2025-01-22	U-1011	Drug product	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022198-001	7608282	2025-01-22	U-1011	Drug product	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022198-001	7608282	2025-01-22	U-1011	Drug product	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022198-001	7608282	2025-01-22	U-1011	Drug product	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022198-001	7608282	2025-01-22	U-1011	Drug product	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022198-001	7608282	2025-01-22	U-1011	Drug product	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022198-001	7608282	2025-01-22	U-1011	Drug product	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022198-001	7608282	2025-01-22	U-1011	Drug product	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022198-001	7608282	2025-01-22	U-1011	Drug product	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022198-001	7608282	2025-01-22	U-1011	Drug product	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022198-001	7608282	2025-01-22	U-1011	Drug product	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022198-001	7608282	2025-01-22	U-1011	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022198-001	7608282	2025-01-22	U-1011	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022198-001	7608282	2025-01-22	U-1011	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022198-001	7608282	2025-01-22	U-1011	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022198-001	7608282	2025-01-22	U-1011	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022198-001	7608282	2025-01-22	U-1011	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022198-001	7608282	2025-01-22	U-1011	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022198-001	7608282	2025-01-22	U-1011	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022198-001	7608282	2025-01-22	U-1011	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022198-001	7608282	2025-01-22	U-1011	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022198-001	7608282	2025-01-22	U-1011	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022198-001	7608282	2025-01-22	U-1011	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022198-001	7608282	2025-01-22	U-1011	Drug product	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022198-001	7608282	2025-01-22	U-1011	Drug product	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022198-001	7608282	2025-01-22	U-1011	Drug product	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022198-001	7608282	2025-01-22	U-1011	Drug product	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022198-001	7608282	2025-01-22	U-1011	Drug product	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022198-001	7608282	2025-01-22	U-1011	Drug product	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022198-001	7608282	2025-01-22	U-1011	Drug product	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022198-001	7608282	2025-01-22	U-1011	Drug product	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022198-001	7608282	2025-01-22	U-1011	Drug product	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022198-001	7608282	2025-01-22	U-1011	Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022198-001	7608282	2025-01-22	U-1011	Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022198-001	7608282	2025-01-22	U-1011	Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022198-001	7608282	2025-01-22	U-1011	Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022198-001	7608282	2025-01-22	U-1011	Drug product	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: SANCUSO
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GRANISETRON	3.1 mg/24h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WZG3J2MCOL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
825003	Internal RxNorm lookup
825005	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7379369a-03df-4ec3-8f2e-66645cc736d8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cfd5f35c-827b-432c-9fef-0869f8899c80	Product name	1	20260105
bd0ef290-bb63-6056-ab17-adf968a44900	Product name	2	20170616
d7be5b36-17f0-843a-22b1-df15cb96e594	Product name	3	20170616
e5d20d92-e4d9-43c9-9475-8f368311d104	Product name	2	20170501
5a6fb99e-671a-4b1d-a9dc-1e7566682136	Product name	1	20160831
5c6cdff6-4525-6e4a-2964-09019d52be11	Product name	1	20140508
ae524849-1812-2c3b-219e-58a687215e77	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66220-637-31	SANCUSO	168 h in 1 POUCH	PATCH	168		4
66220-637-72	SANCUSO	168 h in 1 POUCH	PATCH	168		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66220-637-31	EA - Each	66220-637	8d445958-0464-4627-82e0-d392975d8798	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66220-637	SANCUSO (GRANISETRON) PATCH [CUMBERLAND PHARMACEUTICALS INC.]	4	Current NDC, 2 package rows	20241105_7379369a-03df-4ec3-8f2e-66645cc736d8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SANCUSO	GRANISETRON	Cumberland Pharmaceuticals Inc.	7379369a-03df-4ec3-8f2e-66645cc736d8	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022198 application number: NDA022198 ndc (product): 66220-637

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WZG3J2MCOL	GRANISETRON	109889-09-0	GRANISETRON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
825003	granisetron 3.1 MG/Day 7 Day Transdermal System	PSN	7379369a-03df-4ec3-8f2e-66645cc736d8	4
825005	Sancuso 3.1 MG/Day 7 Day Transdermal System	PSN	7379369a-03df-4ec3-8f2e-66645cc736d8	4
825005	168 HR granisetron 0.129 MG/HR Transdermal System [Sancuso]	SBD	7379369a-03df-4ec3-8f2e-66645cc736d8	4
825003	168 HR granisetron 0.129 MG/HR Transdermal System	SCD	7379369a-03df-4ec3-8f2e-66645cc736d8	4
825005	168 HR Sancuso 0.129 MG/HR Transdermal System	SY	7379369a-03df-4ec3-8f2e-66645cc736d8	4
825003	granisetron 3.1 MG/Day 7 Day Transdermal System	SY	7379369a-03df-4ec3-8f2e-66645cc736d8	4
825003	granisetron 3.1 MG/Day Weekly Transdermal Patch	SY	7379369a-03df-4ec3-8f2e-66645cc736d8	4
825005	Sancuso 3.1 MG/Day 7 Day Transdermal System	SY	7379369a-03df-4ec3-8f2e-66645cc736d8	4
825005	Sancuso 3.1 MG/Day Weekly Transdermal Patch	SY	7379369a-03df-4ec3-8f2e-66645cc736d8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
66220-637-31	66220063731	168 h in 1 POUCH (66220-637-31)	168 h	2024-07-16	No	No	Current
66220-637-72	66220063772	168 h in 1 POUCH (66220-637-72)	168 h	2024-07-16	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SANCUSO - Cumberland Pharmaceuticals Inc.	Cumberland Pharmaceuticals Inc.	2024-11-04	HUMAN PRESCRIPTION DRUG LABEL	4